Learn more about OpenTrialsFDA

The OpenTrialsFDA team is one of the three finalists for the Open Science
Prize. This is a collaboration between Dr. Erick Turner, Dr. Ben Goldacre and the
OpenTrials team at Open Knowledge
International. The work is closely related to the OpenTrials project, which
aims to locate, match, and share all publicly accessible data and documents,
on all trials conducted, on all medicines and other treatments, globally.

OpenTrialsFDA works on making clinical trial data from the FDA (the US Food and Drug
Administration) more easily accessible and searchable. Until now, this
information has been hidden in the user-unfriendly Drug Approval Packages that
the FDA publishes via its dataportal [email protected].
OpenTrialsFDA extracts the relevant data from the FDA documents, link it to
other clinical trial data and present it through this new user-friendly web
interface. Any user can type in a drug name, and see all the places where this
drug is mentioned in a FDA document. This information is also available
via the OpenTrials API.

Unlocking the trove of FDA clinical trials data

Drug Approval Packages report the methods and results of all
premarketing clinical trials, both published and unpublished. Interestingly,
the FDA data is unbiased, compared to reports of clinical trials in academic
journals. This is because FDA reviewers, unlike most academic journal
reviewers and editors, have access to the original trial protocol and can
spot and reject any attempts at post hoc changes to planned outcomes and
statistical analyses. Therefore, a systematic review (SR) or meta-analysis
(MA) based on FDA Drug Approval Packages, which includes unpublished and
“unspun" trial results, will often conclude that the drug in question is less
safe and/or less effective than what one would conclude from a conventional
SR or MA based solely on the published literature.

Unfortunately, despite their high value, these FDA documents are notoriously
difficult to access, aggregate, and search. The [email protected] website itself is
not intuitive to navigate, and the reviews are stored as individual PDFs
which, except for relatively new drugs, cannot be searched. As a consequence,
they are rarely used by clinicians and researchers. OpenTrialsFDA will
improve this situation, so that valuable information that is currently hidden
away can be discovered, presented, and used to properly inform evidence-based
treatment decisions.

The OpenTrialsFDA prototype

The team has scraped the FDA website and extracted the relevant information
from the PDFs through a process of OCR (optical character recognition). Through
this new OpenTrialsFDA interface, users will be able to explore and discover
the FDA data. In addition, the information will be integrated into the OpenTrials database, so
that the FDA report can be linked to reports from other sources, such as
ClinicalTrials.gov, EU CTR, HRA, WHO ICTRP, and PubMed.

The six finalists of the Open Science Prize presented their prototypes at
the BD2K
Open Data Science Symposium on 1 December 2016. Following a public voting
period in December 2016, the team was voted as one of the top 3 finalists and
is currently in the final round. This top 3 will undergo a final expert review
process, after which the winner of the Open Science Prize will be announced in
March 2017 to receive the grand prize of $230,000.

More information

If you want to find out more about OpenTrialsFDA, please check our Frequently Asked Questions. You can also read up on the
work in the series of blog posts we published in the months leading up to the
prototype demonstration: